PRINCIPAL ACTIVITIES PERFORMED BY THE INCUMBENT

*Oversees product transfers from third party manufacturers and other global Fresenius Kabi sites in line with project scope and in compliance with current GMP and regulatory requirements.

*Oversees the life cycle of all products related to biologics from the transfer of product to the plant in Stage 1, to product launch (Stage 2) and continues through process verification (Stage 3).

*Oversees the cleaning requirements and prevention of cross contamination for non-dedicated equipment.

*Leads a team of engineers and scientists responsible for the effective technology transfer of processes into Manufacturing, including the evaluation, alignment and recommendation of equipment/process improvements, for both internally and externally developed processes.

*Collaborates with the FK team on product transfers, defining the validation strategy and alignment of process enhancements during the transfer phase of the product.

*Supports manufacturing in the technical aspects of biologicals, the preparation and review of documentation, compiling of process data, and provides technical input in the deviation investigation, change controls, and CAPAs.

*Works cross functionally with Innovation and Development, Manufacturing, Quality Assurance, Quality Control, Supply Chain, and Facilities departments to effectively transfer and maintain processes in the facility.

*Works closely with manufacturing to provide on-the-floor technical oversight before and during GMP runs.

Additionally:

*Ensures department personnel are aware of the Environmental Management and Energy Management Systems and promotes continual improvement taking accountability for the effectiveness of the Environmental Management and Energy Management Systems according to ISO 14001 and ISO 50001 standards.

*Responsible for ensuring that Health, Safety and Environmental requirements are met under ISO 14001 standards.

*Responsible for ensuring that Energy Management Requirements are met under ISO 50001 standards.

*Responsible for ensuring compliance to Occupational Health and Safety is met under ISO 45001.

REQUIREMENTS

*BS in Science or Engineering with minimum of 12 years industry experience, Masters with 8 years industry experience or PhD with 5 years industry experience

*Must have demonstrated expertise in drug product processes and operations

*Expertise with technical transfer, scale up, and process validation is required

*Experience with GMP compliance requirements is required

*Solid understanding of drug product process development and cGMP production operations

*Experience working in a cGMP manufacturing environment is a plus

*Demonstrated leadership capabilities to develop a high performing team, drive change and influence internal and external stakeholders

*Excellent verbal and written communication skills required

We offer an excellent salary and benefits package including medical, dental and vision coverage, as well as life insurance, disability,401K with company match, andwellness program.

Fresenius Kabi is an Equal Opportunity/Affirmative Action employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, citizenship, immigration status, disabilities, or protected veteran status.